Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Primary Purpose
Cigarette Smoking, Schizophrenia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
varenicline
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cigarette Smoking
Eligibility Criteria
Inclusion Criteria:
- Age 18-64
- Regular ten cigarette per day smoker for one year
- Nicotine Dependency Score greater than or equal to four
- DSM-IV Diagnosis of Schizophrenia or Schizoaffective disorder
- Psychiatric medication regimen unchanged for at least 90 days
- Psychiatric medication dosage unchanged for at least 30 days
Exclusion Criteria:
- Psychiatric hospitalization in last 6 months
- Meets criteria for current Major Depressive Disorder or has a score of greater than 10 on the Calgary Depression Scale (see withdrawal criteria)
- Suicide or homicide ideation with a plan in the last six months
- Life time history of suicide attempt
- Has had a diagnosis of Schizophrenia or Schizoaffective disorder for less than three years
- Current treatment with Bupropion SR
- DSM-IV diagnosis of alcohol or substance dependence within last 6 months*
- DSM-IV diagnosis of alcohol or substance abuse within three months *
- Pregnancy or lactation in females (+HCG)
- Use of tobacco product other than cigarettes
- Use of nicotine replacements
- Unstable or serious medical condition in last 6 months
- Regular use of cimetidine (OTC or Rx) *Substance abuse/dependency exclusions do not apply to abuse of or dependence on nicotine.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
varenicline
placebo
Arm Description
Outcomes
Primary Outcome Measures
Change of ExpiredCO Level From Baseline
End expired carbon monoxide (CO) level change from baseline to determine participants' level of smoking reduction by treatment assignment. Larger negative values represent a greater level of smoking reduction.
Level of Nicotine Dependence by Treatment Assignment
Nicotine dependence was measured using the total score from the Fagerstrom Test for Nicotine Dependence (FTND) assessment. The total score is computed by adding the scores from the five subscales. Total scores range from 1-10, with lower scores representing a smaller degree of nicotine dependence.
Secondary Outcome Measures
Brief Psychiatric Rating Scale (BPRS) - Total Score
The total BPRS score is calculated by adding the scores for subscales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.
Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.
Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score
The anxiety/depression score is calculated by adding the scores for scales #2 Anxiety and #9 Depressive Mood. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum anxiety/depression score is 2 and the maximum psychosis score is 14. A higher score indicates a more severe anxiety/depression rating.
Side Effects
Side effects (33 items) were measured using a Side Effects Checklist (SEC). The percentage of participants endorsing each side effect were reported regardless of the severity or relation to study drug.
Full Information
NCT ID
NCT00554840
First Posted
November 6, 2007
Last Updated
March 16, 2022
Sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00554840
Brief Title
Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Official Title
Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.
Detailed Description
The primary objective of the data analysis will be to measure the rate of smoking cessation in the two treatment groups. Smoking cessation will be measured weekly through a composite measure of self-reported abstinence, end expired carbon monoxide (CO) of less than C10 ppm and urine cotinine dipstick measure of < 30 ng/ml. The primary endpoint will be point prevalence at 12 weeks. The four week continuous abstinence rate for the last four weeks of the treatment phase will also be evaluated. The point prevalence abstinence rates will also be obtained. The secondary objective is to determine whether smoking cessation is associated with a worsening of cognition and psychiatric symptomology. We hypothesize that subjects who achieve abstinence in the varenicline group will not show worsening on neurocognitive and symptom measures compared to abstinence subjects in the placebo group. Lastly, we will attempt to identify any clinical or topographic markers which predict cessation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cigarette Smoking, Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
varenicline
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
varenicline
Other Intervention Name(s)
chantix, study drug
Intervention Description
Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
sugar pill
Intervention Description
At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
Primary Outcome Measure Information:
Title
Change of ExpiredCO Level From Baseline
Description
End expired carbon monoxide (CO) level change from baseline to determine participants' level of smoking reduction by treatment assignment. Larger negative values represent a greater level of smoking reduction.
Time Frame
Weekly for 12 weeks
Title
Level of Nicotine Dependence by Treatment Assignment
Description
Nicotine dependence was measured using the total score from the Fagerstrom Test for Nicotine Dependence (FTND) assessment. The total score is computed by adding the scores from the five subscales. Total scores range from 1-10, with lower scores representing a smaller degree of nicotine dependence.
Time Frame
Weekly for 12 weeks
Secondary Outcome Measure Information:
Title
Brief Psychiatric Rating Scale (BPRS) - Total Score
Description
The total BPRS score is calculated by adding the scores for subscales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.
Time Frame
Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
Title
Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
Description
The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.
Time Frame
Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
Title
Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score
Description
The anxiety/depression score is calculated by adding the scores for scales #2 Anxiety and #9 Depressive Mood. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum anxiety/depression score is 2 and the maximum psychosis score is 14. A higher score indicates a more severe anxiety/depression rating.
Time Frame
Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
Title
Side Effects
Description
Side effects (33 items) were measured using a Side Effects Checklist (SEC). The percentage of participants endorsing each side effect were reported regardless of the severity or relation to study drug.
Time Frame
Weekly for 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-64
Regular ten cigarette per day smoker for one year
Nicotine Dependency Score greater than or equal to four
DSM-IV Diagnosis of Schizophrenia or Schizoaffective disorder
Psychiatric medication regimen unchanged for at least 90 days
Psychiatric medication dosage unchanged for at least 30 days
Exclusion Criteria:
Psychiatric hospitalization in last 6 months
Meets criteria for current Major Depressive Disorder or has a score of greater than 10 on the Calgary Depression Scale (see withdrawal criteria)
Suicide or homicide ideation with a plan in the last six months
Life time history of suicide attempt
Has had a diagnosis of Schizophrenia or Schizoaffective disorder for less than three years
Current treatment with Bupropion SR
DSM-IV diagnosis of alcohol or substance dependence within last 6 months*
DSM-IV diagnosis of alcohol or substance abuse within three months *
Pregnancy or lactation in females (+HCG)
Use of tobacco product other than cigarettes
Use of nicotine replacements
Unstable or serious medical condition in last 6 months
Regular use of cimetidine (OTC or Rx) *Substance abuse/dependency exclusions do not apply to abuse of or dependence on nicotine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Weiner, M.D.
Organizational Affiliation
Maryland Psychiatric Research Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
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